GlaxoSmithKline’s Shingrix shortage expected to persist ‘throughout 2019’

In the face of “unprecedented” demand for its shingles vaccine, GlaxoSmithKline is doing everything it can to boost supply. But in spite of those efforts—it shipped as much vaccine in the third quarter as it did in the first half of the year—GSK says the Shingrix shortage will persist into 2019.

Over the next two to three years, the company intends to significantly boost shipments to the U.S., with plans to grow its overall capacity to the “high teen millions” annually, spokesman Sean Clements said.

But for now, the unexpected uptake for the vaccine in the U.S. has overwhelmed the company’s ability to keep up, forcing it to take steps like implementing order limits and delaying TV advertising.

“Because healthcare professionals continue to vaccinate at a rate many times that of previous years, we expect ordering limits to continue throughout 2019 to help us ensure that vaccine is distributed fairly and equitably where it is needed,” Clements added.

GSK makes the shots, which take 6 to 9 months to produce, at a plant in Belgium. In the face of an expected approval, GSK had stockpiled some “critical elements” to shorten production timelines after approval. Even with that effort, the company hasn’t been able to keep up with demand. For consumers, the shortage means pharmacies have long wait lists or no wait lists at all, according to reports.

GlaxoSmithKline’s new shingles vaccine won U.S. approval last fall and has surpassed early sales estimates. About 7 million doses had been administered as of September. For 2018, the company is expecting £700 million to £750 million in sales for Shingrix.

The vaccine supplanted Merck’s Zostavax on the market and has seen higher demand than its predecessor due to its strong efficacy. Plus, U.S. vaccine advisers recommended Shingrix for people 50 and older, giving GSK a target population of 115 million adults, executives have said.

“We need to get the supply expanded as fast as possible, because we can pretty much sell anything that we can make now in the U.S.,” GSK’s Luke Miels, global pharmaceuticals president, told analysts on the company’s third-quarter conference call.

As the shortage continues, GSK has held off on TV advertising for the product.

https://www.fiercepharma.com/pharma/glaxosmithkline-shingrix-shortage-expected-to-persist-throughout-2019-cdc-says